FDA applicant

Kontron Medical Systems Sas

Redmond, WA4 decisions2000–20060 recalls

FDA records 4 decisions for Kontron Medical Systems Sas (Redmond, WA) from 2000 to 2006: 4 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 3 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Kontron Medical Systems Sas’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kontron Medical Systems Sas since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kontron Medical Systems Sas by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kontron Medical Systems Sas’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Kontron”

FDA records each applicant name separately; these may or may not be the same firm.

Kontron Instruments, Inc. 58 Kontron Electronics 3 Kontron, Inc. 1 Kontron Elektronik GmbH 1

Kontron Medical Systems Sas

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Kontron”